The purpose of this research study is to learn about the safety of transplanting lungs obtained from non-heart-beating donors (NHBDs) that have been ventilated (attached to a breathing machine or ventilator to deliver oxygen) and perfused with a lung perfusion solution (Steen solution™, made by Vitrolife). This ventilation and perfusion will be done outside the body (ex-vivo) in a modified cardiopulmonary bypass circuit (the kind of device used routinely during most heart surgeries). The purpose of performing ex-vivo perfusion and ventilation is to learn how well the lungs work, and whether they are likely safe to transplant.

Further study details as provided by Tom Egan, MD,MsC, University of North Carolina, Chapel Hill:

Primary Outcome Measures:

30 Day Mortality and Graft Survival [ Time Frame: 30 Days ]

The primary objective evaluated for this study is recipient mortality and graft survival at 30 days post transplant. 30 day mortality and graft survival is used as a standard research assessment to evaluate post transplant outcomes.

Primary Lung Graft Dysfunction (PGD) [ Time Frame: 24 and 72 hours ]

Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity and mortality after lung transplantation.

Secondary Outcome Measures:

ICU Length of Stay [ Time Frame: Time to Discharge. ]

The length of ICU stay is another standard research and clinical outcome assessment post transplant and has been selected as a secondary objective.

Day 7 Ventilator/ECMO Status [ Time Frame: 7 Days Post Transplant. ]

7 days ventilator or extra-corporeal membrane oxygenator (ECMO) free are being evaluated as secondary objectives.

Recipient mortality at 12 months. [ Time Frame: 12 months ]

Recipient mortality at 12 months post transplant is being evaluated as a secondary objective.

After EVLP, lungs will be cooled in the circuit to room temperature, then flushed with cold Perfadex™, and taken to UNCH where they will have an ex-vivo CT scan. Lungs determined suitable will be offered to consented patients at UNC Hospitals and Duke University Medical Center based on Lung Allocation Score. Lungs not considered for transplantation may be subjected to different experiments but are not to be a part of this research study. In summary, lungs with good and stable function during EVLP will be transplanted into recipients as per current clinical practice.

Device: STEEN Solution™

This solution is a buffered dextran and albumin-containing extracellular perfusate with an optimal colloid osmotic pressure developed specifically for extra-corporeal perfusion of lungs.

Recipient does not have HIV, active Hepatitis or is colonized with Burkholderia cepacia.

Potential subjects who have undergone previous lung transplants and meet all other inclusion criteria, are eligible for study participation.

Exclusion Criteria:

•Recipient fails to meet standard of care requirements for lung transplant, or decides not to participate.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615484